Disease Related Malnutrition
Conditions
Brief summary
The goal of this study is to learn whether a new oral nutritional supplement is acceptable to adults who are malnourished, or at risk of malnutrition, and need nutritional support. The main questions it aims to answer are: * Do participants tolerate the supplement without stomach or bowel problems? * How much of the prescribed supplement do participants take each day? * How do participants rate the taste, texture and overall experience of taking the supplement? Researchers will also record any side effects. Participants will: * Take the supplement every day for 7 days, as prescribed by their dietitian * Keep a daily diary of how much they take and any stomach or bowel symptoms * Complete a short questionnaire about the supplement and have a review with the study team on Day 7
Interventions
DIETARY_SUPPLEMENTOral nutritional supplementation
A Food for Special Medical Purposes taken orally, one or two servings a day as prescribed by the study dietitian, for 7 days.
Sponsors
Aymes International Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or over * Male or female * Malnourished or at risk of malnutrition, identified using a validated screening tool (e.g. Malnutrition Universal Screening Tool (MUST) score of 1 or more), and/or currently using or requiring oral nutritional supplements as part of a nutritional management plan * Expected to take at least one serving of the study product per day (some participants may be prescribed two servings per day, depending on individual nutritional requirements) * Able to provide written or electronic informed consent, or verbal consent countersigned by an independent witness if physically unable to sign
Exclusion criteria
* Receiving exclusive enteral or parenteral nutrition (no oral intake) * Known allergy or intolerance to any ingredient in the study product, including milk, or any dietary requirement or preference incompatible with its composition (e.g. vegan) * Acute illness or unstable medical condition that may interfere with participation (e.g. major hepatic or renal dysfunction such as decompensated liver disease) * Currently in intensive care * Participation in another interventional clinical study within 2 weeks before this study * Insufficient proficiency in the English language * Lacking the mental capacity to provide informed consent * Investigator concerns about the participant's ability or willingness to comply with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal tolerance | Baseline and daily from Day 1 to Day 7 | Participants record gastrointestinal symptoms each day in a diary: nausea, vomiting, bloating, abdominal pain, constipation, diarrhoea, and burping or flatulence. Each symptom is rated none, mild, moderate or severe. Bowel movement frequency and stool type are recorded each day using the Bristol Stool Chart. Results are reported as how often each symptom occurs and how severe it is, compared with symptoms recorded at baseline. |
| Compliance with the prescribed oral nutritional supplement | Daily from Day 1 to Day 7 | Participants record each day in a diary the number of servings prescribed and taken, and the reasons for any missed or partly taken servings. Compliance is reported as the percentage of prescribed servings each participant took over the study period. |
| Palatability of the oral nutritional supplement | Day 7 | Participants complete a questionnaire rating appearance, smell, taste, texture, aftertaste, convenience and how pleasant the supplement is to take. Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Overall satisfaction is rated on a 5-point scale from 1 (very dissatisfied) to 5 (very satisfied). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Day 1 to Day 7 | The investigator records all adverse events, including the number of participants with at least one adverse event, how severe each event was (mild, moderate or severe) and whether it was related to the study product (from not related to highly probably related). Serious adverse events are also reported. |
Countries
United Kingdom
Outcome results
None listed